Per fda medwatch/user facility report (b)(4), the patient had a percutaneous endoscopic gastrostomy tube placed on (b)(6) 2020.Three t fasteners were placed to anchor the gastric wall against the intra-abdominal wall.An 18fr gastrostomy tube (g tube) was placed and the retention balloon filled with 10cc saline.The patient was discharged from the hospital on (b)(6) 2020.The patient woke up on (b)(6) 2020 with left lower quadrant abdominal pain.Flushing the tube reduced the pain, however, after awaking from a nap the patient experienced "excruciating pain" in the left abdomen that radiated up to the left shoulder.In the emergency department, a ct scan showed "malpositioned displaced g-tube (extraluminal) with mild loculated abdominopelvic fluid and several foci of gas adjacent to the stomach." the g tube was intact through the abdominal wall but was no longer in the stomach.The patient was taken to the operating room on (b)(6) 2020.The t fasteners had been removed a couple days previous.The surgeon reported "a hole/perforation of the posterior stomach along the greater curvature.There was also some purulent fluid in the abdominal cavity." the balloon was found to have only 1 cc of fluid in it.The surgeon tested the balloon by adding additional saline, and no leak was detected.The surgeon placed a new g tube and two purse-string silk sutures.The patient was discharged on (b)(6) 2020.Additional information has been requested but not received.
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